REMEGEN (09995) rose more than 7% intraday, with gains narrowing to 5.57% by the time of writing, trading at HK$81.5 with a turnover of HK$310 million.

The surge follows the release of clinical data for its self-developed PD-1/VEGF bispecific antibody, RC148, at the 2025 European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO) in London on December 10. The Phase I/II trial (RC148-C001) evaluated RC148 as monotherapy and in combination for first- or second-line treatment of non-small cell lung cancer (NSCLC).

Key findings showed that RC148 (20 mg/kg Q3W) combined with docetaxel demonstrated superior efficacy, achieving an objective response rate (ORR) of 66.7% and a disease control rate (DCR) of 95.2%. Efficacy benefits were observed across subgroups, with an ORR of 80% in PD-L1-positive (TPS ≥1%) patients. Median progression-free survival (mPFS) was 8.3 months after a median follow-up of approximately 7 months.

In August this year, RC148 received FDA approval to proceed with Phase II trials in the U.S. Earlier, in 2023, it was approved in China for clinical studies as monotherapy and in combination for advanced solid tumors. The FDA's Investigational New Drug (IND) clearance marks its entry into global clinical development.

The PD-1/VEGF bispecific antibody space is heating up globally, with companies like Akeso and 3SBio already securing overseas licensing deals. REMEGEN's RC148, advancing rapidly in clinical trials, demonstrates strong potential for international expansion, bolstered by its U.S. clinical progress.